POS1485-HPR DIGITALLY ENHANCED TREAT-TO-TARGET AND SHARED DECISION-MAKING APPROACH WITH A DIGITAL HEALTH APPLICATION: INTERIM RESULTS FROM A RANDOMIZED CONTROLLED TRIAL
Authors: J. Knitza, M. Grahammer, S. Boeltz, J. Lang, M. Detert, M. Bader, A. Kleyer, D. Simon, G. Krönke, G. Schett, J. Detert
Journal: Annals of the Rheumatic Diseases (2022)

Background Digital health applications (DHA) became indispensable patient companions accelerated by the current COVID pandemic [1]. In 2020, for the first time worldwide, a regulatory framework to reimburse DHA was established in Germany. To get listed as a DHA, preliminary evidence needs to be generated – next to fulfilling highest standards in quality and safety. The DHA ABATON RA consists of two parts; 1) digital shared-decision-making (SDM) including choosing an appropriate electronic patient reported outcome (ePRO) instrument and the respective ePRO target for the next visit, 2) remote patient monitoring and ePRO tracking by the patient. Hereby, ABATON RA supports a digitally guided Treat-to-Target (T2T) approach. Objectives The objective of this study is to evaluate a potentially beneficial effect for the patient by using ABATON RA. Methods Three-armed, partially blinded multicenter trial (RCT) including RA patients who regularly use a smartphone. Patients attend 3 visits, 3 months apart (T0, T3, T6), with one follow-up visit (T9). Intervention group (IG): Patients use ABATON RA. Via SDM patients and rheumatologists choose a specific ePRO and respective treatment target for the next visit in three months, e.g. RAID ≤4. Control group (CG): Standard of care treatment (no DHA). Placebo group (PG): Usage of a placebo version of ABATON RA providing only Regensburger Insomnie Skala (RIS) and Epworth Sleepiness Scale (ESS) as ePROs. No SDM is conducted and ePRO results are not presented to HCP. Results This interim analysis evaluated the first 38 patients that completed T3. IG: 13 patients (Av. age 55.9, 61.5% females); PG: 12 (Av. age 50.7, 66.7% females); CG: 13 (Av. age 56.1, 76.9% females). We observe a significant improvement in the mean over time in a pairwise comparison within the intervention group for the following: Pt-GA mean difference of 2.98 (p = 0.025, partial η 2 = 0.353), pain mean difference of 1.46 (p = 0.049, partial η 2 = 0.286) whereas all pairwise comparisons for the two parameters were non-significant in PG and CG. The patient reactions assessment (PRA) score, measuring patient perceived quality of the patient-provider relationship, increased by a mean of 4.15 points in IG, compared to a slight decrease of 1.92 for PG and 2.77 for CG. Conclusion These preliminary findings show beneficial differences among the groups in favor of IG: 1) for quality of life and 2) the physician-patient-relationship. A digitally enhanced therapy is non-inferior to the gold-standard of exclusive in-person treatment. Patients seem willing and able to get involved in an enhanced treat-to-target and shared decision-making approach. References [1]Kernder A, Morf H, Klemm P, Vossen D, Haase I, Mucke J, et al. Digital rheumatology in the era of COVID-19: results of a national patient and physician survey. RMD Open. 2021;7:e001548. Disclosure of Interests Johannes Knitza Consultant of: ABATON GmbH, Vila Health, Grant/research support from: ABATON GmbH, Manuel Grahammer Shareholder of: ABATON GmbH, Employee of: ABATON GmbH, Sebastian Boeltz: None declared, Judith Lang: None declared, Markus Detert: None declared, Maram Bader Employee of: ABATON GmbH, Arnd Kleyer: None declared, David Simon: None declared, Gerhard Krönke: None declared, Georg Schett: None declared, Jacqueline Detert: None declared